HealthyPhase 1NCT02267902
Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229
A Phase 1 study testing DA-1229 in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in United Kingdom.
Trial summary
The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-1229
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 18 to 55
- BMI 18.0 to 30.0 kg/㎡
Who cannot join
- History of any drug or alcohol abuse in the past 2years
- Regular alcohol consumption nin males >21 units per week
- Current smokers and those who have smoked within the last 12months
- Radiation Exposure
- Positive drugs of abuse test result
- Positive HBsAg, HCV Ab, HIV results
Show all 10Show fewer
- Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
- Clinically significant allergy
- Donation of loss of blood within the previous 3 months
- Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects
The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.
- Conditions
- Healthy
- Being tested
- DA-1229
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-1229Drug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ [14C]-DA-1229 Receives: Drug: DA-1229 |
| Part 2 | Experimental | Single oral therapeutic dose of 5mg [14C]-DA-1229 Receives: Drug: DA-1229 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the absolute bioavailability of DA-1229 (F)
Measured: 240 hours
The mass balance recovery (Ae, %Ae)
Measured: 240 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267902
- Sponsor's protocol ID
- DA1229_BAMB_I
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02267902
- Acronym / sponsor ID
- DA1229_BAMB_I
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: DA-1229Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ [14C]-DA-1229 |
| Part 2 | Experimental | Drug: DA-1229Single oral therapeutic dose of 5mg [14C]-DA-1229 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males
- Age 18 to 55
- BMI 18.0 to 30.0 kg/㎡
Key exclusion criteria (10 listed)
- History of any drug or alcohol abuse in the past 2years
- Regular alcohol consumption nin males >21 units per week
- Current smokers and those who have smoked within the last 12months
- Radiation Exposure
- Positive drugs of abuse test result
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-1229 | Drug | Part 1, Part 2 |
Primary outcome
the absolute bioavailability of DA-1229 (F)
Time frame: 240 hours
The mass balance recovery (Ae, %Ae)
Time frame: 240 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-1229 in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the absolute bioavailability of DA-1229 (F) (time frame: 240 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.